Ji, Dongmei
Wang, Shufang
Yao, Wei
Hou, Denny
Wang, Xiaoyan
Ye, Changsheng
Li, Hongsheng
Yang, Hongjian
Yi, Jilin
Lu, Jinsong
Wang, Haibo
Xu, Xiaohong
Cai, Dongyan
Liu, Xiaoan
Yan, Xi
Nie, Jianyun
Cui, Shude
Jiang, Hongchuan
Cao, Junning
Clinical trials referenced in this document:
Documents that mention this clinical trial
Efbemalenograstim Alfa, an Fc Fusion Protein, Long‑Acting Granulocyte Colony-Stimulating Factor for Reducing the Risk of Chemotherapy-Induced Neutropenia: Results of a Phase II Randomized, Multicenter, Open‑Label Trial
https://doi.org/10.1007/s40261-025-01479-y
Article History
Received: 24 December 2024
Accepted: 27 August 2025
First Online: 9 October 2025
Declarations
:
: The authors declare that they have no competing interests.
: The study was approved by the Institutional Review Boards and Ethics Committees at Fudan University Shanghai Cancer Center (review ID: 1404134-7; approval date: 28 April 2014); Nanfang Hospital of Southern Medical University (review ID: NFEC-2014084; approval date: 24 September 2014); Affiliated Cancer Hospital and Institute of Guangzhou Medical University (review ID: [2014] no. 10; approval date: 25 November 2014); Zhejiang Cancer Hospital (review ID: [2014] no. 23; approval date: 4 June 2014); Tongji Hospital of Tongji Medical College (review ID: XHEC-A-2014-012; approval date: 24 July 2014); Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (review ID: [2014] no. 64; approval date: 12 June 2014); The Affiliated Hospital of Qingdao University (review ID: QYFYEC 2014-018-01; approval date: 8 July 2014); Nantong Tumor Hospital (review ID: 2014-008-01; approval date: 2 June 2014); Affiliated Hospital of Jiangnan University (review ID: 2014-010-02; approval date: 25 July 2014); Jiangsu Province Hospital (review ID: 2015-MD-003 ; approval date: 13 January 2015); West China Hospital of Sichuan University (review ID: [2014] no. 81; approval date: 19 September 2014); Yunnan Cancer Hospital (review ID: YW201409; approval date: 31 December 2014); Henan Cancer Hospital (review ID: 2014ys18; approval date: 1 July 2014); Beijing Chaoyang Hospital of Capital Medical University (review ID: 2014-drug-73; approval date: 14 November 2014). The study was conducted in accordance with the Declaration of Helsinki and the Chinese Good Clinical Practice Guidelines. Written informed consent was obtained from all patients before any study-related procedure was performed.
: Not applicable.
: The datasets from the current study are available from the corresponding author on reasonable request.
: Junning Cao was the coordinating principal investigator of the study and was involved in the development of study protocol, study conduct, and evaluation of the study results. Dongmei Ji, Changsheng Ye, Hongsheng Li, Hongjian Yang, Jilin Yi, Jinsong Lu, Haibo Wang, Xiaohong Xu, Dongyan Cai, Xiaoan Liu, Xi Yan, Jianyun Nie, Shude Cui, Hongchuan Jiang, and Xiaoyan Wang were involved in the study design, preparation, coordination, and evaluation of the trial. Shufang Wang, Wei Yao, and Denny Hou were involved in drafting the manuscript. All authors read and approved the final version and agree to be accountable for the work.